MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS BABYPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number 510A1960

Device Problems Crack (1135); Leak/Splash (1354); Failure to Deliver (2338); Failure to Align (2522); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the pneupac ventilators babypac, which was operating on cmv + peep mode, periodically gave a "high p alarm" flash, and stopped delivering gas.The unit failed to operate as intended on the patient.No death or serious injury was reported in connection with this incident.

Manufacturer Narrative

One pneupac ventilators was returned for analysis.During visual inspection, it was noted both input hoses and exhalation valve cover were not securely fastened.A crack was observed on the eyeball cover, control dials were not central and the i time, e time, cpap, inspiratory pressure control did no align with the calibrated marks.Oxygen concentration control was attempted to be turned 360°; no discrepancies.Functional testing to input hoses; no fault was identified.The unit was set to the settings reported.At the settings that were set, it is noted that these are correct for the high pressure alarm to be activated as the peep level is greater than 10 x 100pa for longer than 8 seconds therefore no fault was identified with this phenomenon.However, the unit did stop delivering gas when pressure was applied to the mode selector/function switch.A constant flow pressure of 30 x 100pa was observed.The unit opened for further investigation.Switch block assembly 510a2198 removed and tested to production test procedure ptp 156.The sub assembly failed to pass all tests due to leak observed.Switch block assembly disassembled for further investigation.Although no damage or debris was observed internally, movement within the poppet due to wear and tear over the past 15 years could have caused a leak past the o-ring causing the continuous flow and unit to stop cycling.Based on the evidence, the complaint was confirmed.The root cause is found due to wear and tear from 15 years of use.

• Brand Name: PNEUPAC VENTILATORS BABYPAC
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7789478
• MDR Text Key: 117328826
• Report Number: 3012307300-2018-03263
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• PMA/PMN Number: K043495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 510A1960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1